Duns Number:255276362
Device Description: The Aortic Prosthesis Indexing Cone is a medical device that is intended to be used to fac The Aortic Prosthesis Indexing Cone is a medical device that is intended to be used to facilitate the location and cutting of two or three equally spaced features on an extremity of an aortic graft prosthesis having a diameter within the range of 20 mm to 34 mm.
Catalog Number
1010605
Brand Name
Aortic Prosthesis Indexing Cone
Version/Model Number
1010605
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
a5ee3ec9-9799-4c46-a811-475a6f6812f3
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |